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United States· US:67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793

Methadone Hydrochloride

A methadon, kombinationen, exkl. psycholeptika product containing methadone hydrochloride, registered in United States by Mylan Institutional LLC.

ATC N02AC52Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMethadone HydrochlorideATCN02AC52REGISTER NO.US:67457-217_868dd5b8…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about methadone hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Methadone Hydrochloride
Manufacturer
Mylan Institutional LLC
Country
United States (US)
ATC code
N02AC52
ATC class
Methadon, Kombinationen, exkl. Psycholeptika
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    6745721720
    1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20) / 20 mL in 1 VIAL, MULTI-DOSE

Regulatory notes

UNII (FDA substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
N021624
AP
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Methadon, kombinationen, exkl. psycholeptika in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All methadon, kombinationen, exkl. psycholeptika products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Methadon G.L., Methasan
  • Belgium · Mephenon
  • Bulgaria · Метадон Алкалоид, Метадон Софарма
  • Czechia · Misyo, Sublana
  • Germany · Methaddict, Methadon G.L. Pharma
  • Denmark · Marlodon, Metadon
  • Estonia · Metadon Dak
  • Spain · Eptadone, Metasedin
  • Finland · Dolmed, Metadon
  • France · Methadone Ap-Hp, Zoryon
  • United Kingdom (Northern Ireland) · Methadone, Methadone Accord Healthcare
  • Greece · Methadone Ι.Φ.Ε.Τ.
  • Croatia · Heptanon, Metadon Alkaloid
  • Hungary · Metadon, Metadon Ep
  • Ireland · Methadone Hydrochloride Alkaloid-Int, Methadone Hydrochloride Ascot Laboratories (Ireland)
  • Iceland · Metadon 2care4, Metadon Abcur
  • Italy · Eptadone, Metadone Cloridrato Molteni
  • Lithuania · Metadon Dak
  • Luxembourg · Mephenon, Methasan
  • Malta · Methadone Alkaloid, Pinadone
  • Netherlands · Eptadone Suikervrij, Methadon Hci Sandoz
  • Norway · Metadon Abcur, Metadon Dne
  • Poland · Methadone Hydrochloride Inn-Farm, Methadone Hydrochloride Molteni
  • Portugal · Misyo
  • Romania · Metadon Bioeel, Methasan
  • Sweden · Metadon, Metadon Abcur
  • Slovenia · Metadonijev Klorid Alkaloid-Int
  • Slovakia · Metagla, Misyo

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/d1b36367-0963-4588-a16a-5730342367b4
GET /v1/drugs/d1b36367-0963-4588-a16a-5730342367b4?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "229809935B",
    "rxcui": "218337",
    "inchikey": "FJQXCDYVZAHXNS-UHFFFAOYSA-N",
    "display_name": "METHADONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "e72841bf-364b-49b1-8e69-7e26ddcd2657": {
      "match": "brand_token",
      "title": "METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA]",
      "spl_version": "18",
      "published_date": "2026-05-20"
    }
  },
  "productid": "67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793",
  "productndc": "67457-217",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021624",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHADONE HYDROCHLORIDE",
  "proprietary_name": "Methadone Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021624",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methadone Hydrochloride",
  "start_marketing_date": "20121220",
  "active_numerator_strength": "10"
}
API referenceMCP serverPlans

See everything about methadon, kombinationen, exkl. psycholeptika.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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